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EDG Ortho 65mm (pack of 10)

by EDGe Surgical, Inc

Ref 21342-65-10-10-LN

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-10865707000435 Basic UDI-DI 10865707000435UDI-DIDate14 Jul 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Device Name
EDG Ortho 65mm (pack of 10)
Model / Reference
21342-65-10-10-LN
Primary DI / UDI-DI
10865707000435
Basic UDI-DI
B-10865707000435
EMDN Code
Z12139085 Various orthopaedic and traumatology instruments - consumables
Device Class
Class IIa
EU market of registration
Greece

Manufacturer details

EUDAMED SRN
US-MF-000052496
Authorised representative
ICON (LR) Limited IE-AR-000006507

Other devices from EDGe Surgical, Inc

Properties

  • Sterile
  • Contains Latex
  • Measuring Function

Other properties (8)

  • Implantable: No
  • Reusable: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No